NCT00164177

Brief Summary

To evaluate the efficacy of standard HalfLYTELY® as a bowel cleansing preparation for adult patients undergoing virtual colonoscopy (VC).

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2004

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
Last Updated

February 7, 2013

Status Verified

February 1, 2013

Enrollment Period

2 months

First QC Date

September 9, 2005

Last Update Submit

February 6, 2013

Conditions

Colonoscopy

Keywords

virtual colonoscopycolonoscopy preparationbowel prep

Outcome Measures

Primary Outcomes (1)

  • Efficacy of the preparation to produce a degree of fecal matter and residual liquid that would not interfere with VC or CC.

Secondary Outcomes (1)

  • Incidence of adverse events.

Interventions

HalfLytelyDRUG

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female outpatients who are undergoing colonoscopy for routinely accepted indications, Evaluation of BE results, GI bleeding, Anemia of unknown etiology, Neoplastic disease surveillance, Endosonography, Inflammatory bowel disease (except as noted below), Unknown diarrhea etiology, Prior Polypectomy, Laser therapy, Foreign body removal and decompression (except as noted below).
  • years of age or older.
  • Otherwise in good health, as determined by physical exam and medical history.
  • If female, and of child-bearing potential, is using an acceptable form of birth control (hormonal birth control, IUD, double-barrier method, or vasectomized spouse)
  • Subject has read and signed the written informed consent document prior to study participation

You may not qualify if:

  • Subjects with known or suspected bowel perforation or obstruction, inflammatory bowel disease, ileus, acute alimentary tract surgery, significant gastroparesis or gastric outlet obstruction, appendicitis, gastric retention, toxic colitis, toxic megacolon or rectal bleeding.
  • Subjects with impaired consciousness that predisposes them to pulmonary aspiration.
  • Subjects with uncontrolled cardiovascular disease
  • Subjects who, in the opinion of the investigator, should not be included in the study for any reason, including inability to follow study procedures.
  • Subjects who have participated in an investigational clinical surgical, drug or device study within the past 30 days.
  • Subjects who are pregnant or lactating.
  • Subjects who are allergic to Polyethyleneglycol.
  • Subjects receiving non-study laxatives, antacids and prokinetic agents during the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Vero Beach, Florida, 32960, United States

Location

Study Officials

  • H. Paul Hatten, Jr., MD

    Indian River Radiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 14, 2005

Study Start

October 1, 2004

Primary Completion

December 1, 2004

Last Updated

February 7, 2013

Record last verified: 2013-02

Locations

US(1)